Spreadsheet Validation

MS Excel and Compliance with 21 CFR Part 11 and Annex 11

Need Validation Help?
Easy-to-create, surprisingly powerful and flexible, spreadsheets are so common they can almost seem invisible. You can use spreadsheets in GMP, GCP, and GLP environments, but as with any computer system, the FDA expects measures to be in place to ensure system data are controlled and protected. This includes password protection to ensure only authorized people can access your data, audit trails to track changes to system data, and user-level security to ensure that system users only perform actions they are authorized to do.

There are two general strategies for spreadsheet compliance with 21 CFR 11 and Annex 11. Our preferred strategy is to provide the necessary technological controls to your spreadsheets, including password protection, audit trails, and electronic signatures. This strategy allows your spreadsheets to be used as data storage tools, with all of the advantages that provides. We can also validate and secure your spreadsheets for temporary formatting and data calculation.

Experts in MS Excel Spreadsheet Validation

Ofni Systems is an industry leader in MS Excel spreadsheet validation. We have helped the FDA Office of Regulatory Affairs ensure that their spreadsheets are compliant with 21 CFR 11. We have validated MS Excel spreadsheets used by small startups and Fortune 500 companies. Our validation experts have given presentations on all aspects of spreadsheet validation and MS Excel compliance with 21 CFR 11 and Annex 11. We know the strategies for designing compliant spreadsheets, addressing the compliance risks associated with spreadsheets, and how to protect spreadsheet data throughout the data retention period.

Our spreadsheet validation experts will work with you to understand how your spreadsheet fits within your existing processes and the validation strategy that works best for you. We will review the spreadsheet calculations, test macros, and VBA script and ensure that your spreadsheet behaves as you expect. We understand where the compliance risks exist in spreadsheets and will focus our testing on the high-risk aspects. Results of spreadsheet validation testing are efficiently compiled into a validation package that documents your compliance.

Benefits of Spreadsheet Validation

Validation is required by the FDA to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. At Ofni Systems, we view validation as an opportunity to add value to your computer systems. Validating your spreadsheet allows you to:

• Submit data to regulatory organizations
• Use data to make quality and GxP decisions
• Control your data and define who has access to the data
• Ensure your spreadsheet performs to specifications
• Query your data to better understand your business process
• Have documented evidence that your processes work as expected
• Have increased confidence in your system

Additional Spreadsheet Validation Resources

• ExcelSafe – Ofni Systems industry-leading tool for ensuring MS Excel spreadsheet compliance with 21 CFR 11.
• Compliance Resources – Informational pages about validation and 21 CFR 11
• Compliance Training – Ofni Systems can teach you to develop spreadsheets for GxP environments. Ofni Systems can also teach you to validate your spreadsheets.